Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of 17/607,003
Claims 1, 3-19, 26, and 33-38 are currently pending.
Priority
The instant application 17/607,003, filed 10/27/2021, claims priority as follows:
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The effective filing date of a claimed invention is determined on a claim-by-claim basis. See MPEP § 2152.01.
The priority document US Provisional Application No. 62/841,600 fails to provide support under 35 U.S.C. 112 for Z as cycloalkyl in Formula I, as in claim 1. Thus, claims 1, 2, 15-19, and 26, which contain limitations drawn to these features are not entitled to an effective filing date of 5/1/2019.
The priority document PCT/US2020/031058 contains support for the limitations of claims 1, 2, 15-19, and 26. Therefore, claims 1, 2, 15-19, and 26 are entitled to an effective filing date of 5/1/2020.
Information Disclosure Statement
All references from the IDS submitted on 10/27/2021, 8/19/2022, 2/6/2024, 6/11/2025, and 12/3/2025 have been considered unless marked with a strikethrough.
Response to Arguments/Amendments
The amendment filed 12/3/2025 has been entered. Claims 1, 36, and 37 are currently amended. Claim 2 has been cancelled, and claim 38 has been added but is not considered new matter.
Claim 17 was rejected under 35 U.S.C. 112(d) in the Non-Final dated 9/18/2025 for failing to further limit the subject matter of the claim upon which it depends. Applicant’s arguments regarding the limitation “an effective amount of a compound of claim 1 for treating a hyperproliferative disease” have been considered, and are partially persuasive. The limitation “effective amount” of claims 16 and 17 has been reinterpreted as a compositional limitation in accordance with Applicant’s arguments. However, the method of using the compound or composition recited in the body of a claim, when the preamble recites the compound or composition, is indefinite according to MPEP § 2173.05(p)(II) and can be rejected under 112(b). See below.
In the Non-Final dated 9/18/2025, claim 37 was rejected under 35 U.S.C. 112(b) for a lack of antecedent basis. In response, Applicant amended claim 37, which overcomes the rejection. Thus, the rejection is withdrawn.
Claims 1, 15-17, and 36 were rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) in the Non-Final dated 9/18/2025. Upon Applicant’s cancellation of claim 2 and incorporation of the limitations into claim 1, the rejection of claims 1 and 15-17 has been overcome. Additionally, Applicant’s amendment of claim 36 to omit the recitation of -N(CH3)2 overcomes the second 102 rejection of the Non-Final. Thus, the rejections are withdrawn.
However, upon expansion of the scope of the search, new rejections were identified and are the subject of this Office Action. See below.
Election/Restriction
Applicant’s election of Group I, claims 1-17, without traverse in the reply dated 12/17/2024 is acknowledged. Applicant’s election of compound KH-19:
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As the single species of Formula (I) and election of breast cancer as the single species of hyperproliferative disease with HuR overexpression, without traverse, is also acknowledged.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
In the Non-Final dated 2/5/2025, the elected species was searched and no applicable prior art was identified. In the same Office Action, the Examiner expanded her search to compounds of Formula IB, and identified prior art. After Applicant’s amendment filed 4/15/2025, the expanded species rejections of claims 1-5, 7-11, and 13-14 under 35 U.S.C. 102 and claim 15 under 35 U.S.C. 103 were withdrawn. In the Final Rejection dated 5/12/2025, the Examiner moved onto expand the scope of the search to compounds of Formula (IA):
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Where X1 is S and L1 is absent and prior art was identified. In response, Applicant amended claim 1 to omit the limitation where L1 is absent, thus overcoming the rejections of claims 1-6, 8, and 15. However, Applicant added new claim 36, which reads on the expanded species of Formula (IA) where X1 is S and L1 is absent. In the interest of compact prosecution, the expanded species of Formula (IA) where X1 is S and L1 is absent that now reads on claim 36 was examined in the Non-Final dated 9/18/2025. In addition to the expanded species listed above, the search was expanded to alternative species of Formula I recited in the claims examined previously. No additional prior art was identified where Z1 of Formula I is an aryl group or a cyclohexyl group, and thus the search was expanded to where Z1 is cycloalkyl. The search was expanded to compounds of Formula I:
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Where Z1 is cycloalkyl, X1 is NH and L1 is CH2. Upon cancellation of claim 2, incorporation of the limitations of claim 2 into claim 1, and the amendment to claims 36 and 37 to omit the limitation of -N(CH3)2, the 102 rejections of the Non-Final dated 9/18/2025 have been overcome and withdrawn. The Examiner then expanded the scope of the search to all compounds of Formula I, encompassed by claims 1, 3-17, and 33-35, which were found to be free of the prior art. Thus, the Examiner then expanded the scope of the search to additional compounds of instant Formula IA where L1 is absent, of claims 36-38, and identified prior art. Thus, Group I, claims 1, 3-17, and 33-38, are the subject of this Office Action. Claims 18-19 and 26 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. See MPEP § 803.02.
Claim Interpretation
Claim 16 recites, “effective amount”, in reference to the amount of a compound of claim 1 in a pharmaceutical composition that is able to treat a hyperproliferative disease with HuR overexpression. The phrase “effective amount” is defined in the specification as an amount of compound or composition required to produce a desired effect, and includes examples such as an amount or dosage that yields acceptable toxicity and bioavailability levels for therapeutic (pharmaceutical) use and an amount or dosage that reduces the size of tumors associated with a cancer that exhibits HuR overexpression (page 21, para [0090]). There are no working or prophetic examples in the specification with example amounts or dosages to treat a hyperproliferative disease with HuR overexpression, though there are examples of treating cancers with unknown HuR expression status in the instant disclosure. Furthermore, the “desired effect” stated in the definition is broad, and thus, the “effective amount” is currently being interpreted as any amount or dosage that yields acceptable toxicity and bioavailability levels for therapeutic (pharmaceutical) use or reduces the size of tumors associated with a cancer that exhibits HuR overexpression.
NEW OBJECTIONS AND REJECTIONS NECESSITATED BY AMENDMENT
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites a product and process in the same claim by the phrase, “an effective amount of a compound of claim 1 for treating a hyperproliferative disease”. This renders the claim indefinite because it is unclear as to whether direct infringement occurs when one has the compound, or whether a patient population is also required to measure the effective amount. Dependent claim 17 does not resolve this issue by clarifying when infringement occurs and is therefore also rejected. See MPEP § 2173.05(p)(II). Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 36 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by ACS (American Chemical Society. Chemical Abstract Service. RN 2215026-67-6, SR Chemical Catalog Supplier; Aurora Fine Chemicals. Entered into STN 18 April 2018).
The reference ACS discloses the following compound:
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Which anticipates a compound of instant Formula IA:
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When R1, R3, R4, and R5 are H, R2 is tert-butyl, X1 is S, L1 is absent, and X2 is O-C1 alkyl. Thus, ACS anticipates claim 36.
Claim Objections
Claims 37-38 are objected to as they are dependent on a rejected base claim.
Allowable Subject Matter
Claims 1, 3-15, and 33-35 are allowable over the prior art.
Conclusion
Claims 1, 3-15, and 33-35 are allowed. Claims 16-17 and 36 are rejected. Claims 37-38 are objected to. Claims 18-19 and 26 remain withdrawn
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621